Description

Key Responsibilities

· Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.

· Validate medical imaging workflows, algorithm development processes, data pipelines, and integration with downstream applications.

· Collaborate with data scientists, algorithm engineers, business analysts, QA, and development teams to define validation requirements and acceptance criteria.

· Create and maintain requirements traceability matrices (RTM), test scripts, execution evidence, and defect documentation.

· Support functional, integration, regression, and User Acceptance Testing (UAT), ensuring end-to-end traceability.

· Assess validation impact of system enhancements, algorithm updates, and configuration changes.

· Ensure alignment with applicable GxP, GAMP 5, FDA 21 CFR Part 11, and internal quality standards.

· Support audit readiness, deviation management, CAPA activities, and release validation sign-off.

Required Qualifications

· 5+ years of experience in software validation, CSV, or quality assurance within life sciences, pharmaceutical, or medical technology environments.

· Experience validating cloud-based applications, medical imaging platforms, or regulated software systems.

· Strong understanding of SDLC, Agile methodologies, risk-based validation, and software testing.

· Experience with Jira, Confluence, test management tools, and validation documentation.

· Excellent communication skills and ability to collaborate with cross-functional technical and business teams

Key Skills

Education

Bachelor's degree